MAUDE Adverse Event Report: OREGON MANUFACTURING PLANT NATURALYTE 3301 3K 3.0CA 1MG GAL; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	08-3301-2
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A hemodialysis (hd) clinic biomedical technician (bmt) reported to fresenius customer service that a three batches of naturalyte were resulting in low conductivity during testing/set-up prior to initiating treatment.There was no patient involvement reported.Upon follow up, the bmt reported during setup the conductivity was at 13.2 ms/cm although the theoretical conductivity value (tcd) was set to 13.6 ms/cm.He confirmed no patients were treated with this batch.There was no recent service to the machine.There were a total of 2 cases of each reported lot, however, they were discarded.The hd clinic is utilizing bibags for bicarbonate (unknown product and lot numbers).
Additional Manufacturer Narrative
Plant investigation: a product history review was performed.A review of the complaint management system identified 2 additional complaints related to conductivity issues with the reported lot.A review of the product inventory records for lot no.20lxac092 indicated that 2201 cases of finished product were manufactured for distribution with no noted nonconformances.After reviewing the finished product release summary, it was determined that 20lxac092 met release specifications.As of 12/30/2020 no samples were returned.Samples are not needed to confirm the allegation.Through other complaint allegations of the same issue for lots 20lxac056, 20lxac058, and 20lxac076, there were companion samples available for testing which were tested at both the oregon and irving laboratories and results were found to be conflicting.Due to the conflicting results found between the laboratories, the oregon test methods were reviewed and a deficiency was found in the test method pertaining to the sodium and potassium analyte tests.Because of the deficiency found in the test method, it was determined that lot 20lxac092 did not meet release specifications and the allegation conductivity low was confirmed.In conclusion, 20lxac092 release testing was found to be compromised due to the deficient test method.A non-conformance was opened for allegations of conductivity issues and escalated to a corrective action preventative action (capa).Based on the investigation performed, cause was traced to manufacturing.

• Brand Name: NATURALYTE 3301 3K 3.0CA 1MG GAL
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): OREGON MANUFACTURING PLANT; director, quality systems; 750 n lallendorf road; oregon OH 43616
• MDR Report Key: 10916192
• Report Number: 3005162618-2020-00053
• Device Sequence Number: 14517599
• Product Code: KPO
• UDI-Device Identifier: 00840861101757
• UDI-Public: 00840861101757
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 08-3301-2
• Device Catalogue Number: 08-3301-2
• Device Lot Number: 20LXAC092
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 11/29/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1